DIRECTOR, PRODUCTION QUALITY

Location: Virginia Beach
Department: Quality Engineering
Job Type: Full-Time
Shift: Monday-Friday, Full Time
Clinical Classification: Non-Clinical
LifeNet Health is searching for talented individuals who will embrace our mission of saving lives, restoring health, and giving hope.
LifeNet Health, headquartered in Virginia Beach, Virginia, is the largest nonprofit organ procurement organization (“OPO”) and tissue processor in the United States, as well as a leading innovator in tissue engineering and regenerative medicine. Our goal is to improve the quality of human life through the provision of organs, tissues, and cells for transplantation; to provide innovation in the fields of bio-implants, regenerative medicine and research; and, to serve the community with educational and support services that enhance the donation process. LifeNet Health has over 1200 employees and has a growing global presence.

WHAT YOU’LL BRING (MINIMUM REQUIREMENTS):

• Bachelor’s Degree – Engineering or similar technical/science degree
• TEN (10) years – Quality engineering within the medical device, tissue, biologics, pharmaceutical, or combination product industry, with a focus on design quality
• TEN (10) years – Design control process, V&V activities, risk management, corrective and preventative action investigation and root cause analysis, process flow charts, FMEAs, PFMAs, purchasing controls and control plans
• TEN (10) years – Management/Leadership experience with direct reports (including departmental budgeting experience)
• Auditor Training – Auditor training by a reputed organization (such as BSI, AIAG, etc.,) Current or obtained within 6 months of employment

Preferred Experience/Skills/Certifications:

• Master’s Degree – engineering or similar technical/science degree
• Auditor Training by ASQ (American Society for Quality)
• Certified Quality Engineer (CQE)

THESE WOULD BE NICE TOO (KNOWLEDGE SKILLS AND ABILITIES):

• Project Management: Ability to manage complex projects involving multiple cross-functional teams with tight deadlines
• Communication Skills: Excellent verbal and written communication skills; ability to communicate and build relationships with all professionals at different levels within the organization
• CAPA process: Root cause investigation and determination and corrective and preventive action
• LEAN/Six Sigma: 8D method of problem resolution. Quality Issues correction and prevent recurrence. Knowledge and experience in choosing KPIs in Safety, Quality, Delivery, Productivity, and Cost areas
• Proficient in MS Office: PowerPoint, Excel, Word, Outlook, Microsoft Suite, as position requires
• Time Management: Able to prioritize multiple, competing priorities and manage time/workload. Demonstrated ability to effectively prioritize and juggle multiple time sensitive projects, multi-task, identify project interdependencies and potential risks/pitfalls
• Attention to Detail: Able to perform tasks thoroughly and with care; checks work to ensure high degree of accuracy/completeness and early/on-time delivery
• Teamwork: Ability to be collaborative and work as part of a team to resolve issues, complete tasks, and meet business needs.

Production Quality:

• Ensure that all production activities are conducted in compliance with regulatory requirements and company standards.
• Works with Procurement & applicable Business Units to ensure that components meet established requirements.
• Proactively drives the evaluation, monitoring, and continuous improvement of quality control inspection methods and efficiency opportunities.
• Reviews and coordinates intradepartmental approval of internal and externally generated NCRs, CAPAs, Deviations, and other Quality System inputs using established procedures and work instructions.
• Ensures the nonconforming material identified from receiving, in-process, and finished device acceptance is identified, documented, and communicated to affected parties for timely and effective resolution
• Ensures quality control inspection plans, tests and methods are adequately developed (including test/inspection equipment), implemented, maintained and utilized statistical methodology, where appropriate, for receiving, in-process, and finished product acceptance.
• Responsible for assuring First Article Inspections are completed for all new/modified articles
• Define, justify, acquire and implement inspection test equipment to meet specified needs.
• Provide input on product and process development to ensure manufacturability, reliability, and compliance with quality standards.
• Manage all activities related to Supplier Quality in accordance with policy, including supplier selection and evaluation, material qualification, inspection procedure development, supplier corrective action, supplier assessments, supplier performance reviews and supplier development.